Antibiotic Application

Antibiotic Application
SPL v7
SPL
SPL Set ID da436c35-a98f-4df7-9d23-885564734cef
Route
TOPICAL
Published
Effective Date 2016-08-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bacitracin (400 [iU]) Neomycin (3.5 mg) Polymyxin B (5000 [iU])
Inactive Ingredients
Mineral Oil Petrolatum Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-08-06
Description

Bacitracin zinc (bacitracin 400 units) Neomycin sulfate (neomycin 3.5mg) Polymyxin B sulfate (polymyxin B 5,000 units)

Purpose

First aid antibiotic

Medication Information

Purpose

First aid antibiotic

Description

Bacitracin zinc (bacitracin 400 units) Neomycin sulfate (neomycin 3.5mg) Polymyxin B sulfate (polymyxin B 5,000 units)

Use
  • First aid to help prevent infection in minor cuts, scrapes, and burns.
Warnings

For external use only.

Directions

• Clean the affected area. • Apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily. • May be covered with a sterile bandage.

Do Not Use

• in the eyes • over large areas of the body • if you are allergic to any of the ingredient • longer than 1 week unless directed by a doctor.

Other Information

Store at room temperature

Package Labeling:

Inactive Ingredients

Mineral oil, petrolatum, purified water

Stop Use and Ask A Doctor If

• the condition persists or gets worse • a rash or other allergic reaction develops.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Active Ingredients (in Each Gram)

Bacitracin zinc (bacitracin 400 units)

Neomycin sulfate (neomycin 3.5mg)

Polymyxin B sulfate (polymyxin B 5,000 units)

Ask A Doctor Before Use If You Have

• deep or punture wounds • animal bites • serious burns.

Structured Label Content

Use
  • First aid to help prevent infection in minor cuts, scrapes, and burns.
Purpose

First aid antibiotic

Warnings

For external use only.

Directions

• Clean the affected area. • Apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily. • May be covered with a sterile bandage.

Do Not Use (Do not use)

• in the eyes • over large areas of the body • if you are allergic to any of the ingredient • longer than 1 week unless directed by a doctor.

Other Information (Other information)

Store at room temperature

Package Labeling:

Inactive Ingredients (Inactive ingredients)

Mineral oil, petrolatum, purified water

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

• the condition persists or gets worse • a rash or other allergic reaction develops.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.

Active Ingredients (in Each Gram) (Active ingredients (in each gram))

Bacitracin zinc (bacitracin 400 units)

Neomycin sulfate (neomycin 3.5mg)

Polymyxin B sulfate (polymyxin B 5,000 units)

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

• deep or punture wounds • animal bites • serious burns.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:21.125928 · Updated: 2026-03-14T23:07:01.452935